- Merck & Co. (North Wales, PA)
- … CMC leadership team as appropriate.Provide regulatory leadership as needed in product in- license /due diligence review, product divestment and product ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises… more
- Merck & Co. (Rahway, NJ)
- …a leader both internally and externally with broad expertise in CMC regulatory strategy and dossier management activities across product development, ... for managing a team of CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery of high-quality CMC submissions for products which… more
- Merck & Co. (North Wales, PA)
- …and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve ... and policies and business objectives.Actively- participate in labeling and global regulatory team meetings to ensure support for anticipated promotional… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is seeking a Vaccine Drug Product Development leader responsible for scientific and technical oversight of vaccine drug product ... to establish and maintain a world-class team with expertise in vaccine drug product development. The incumbent is responsible for advancing a culture of scientific… more
- Option Care Health (Dublin, OH)
- …assist in the provision of safe and appropriate pharmacy patient care and support services in accordance with Option Care policies and procedures, state regulations, ... professional standards, and other regulatory requirements. At the Corporate office or remotely, the...or remotely, the Pharmacy Resident assists in the on-going support of field clinical services, and supervises the Drug… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Associate Director of GXP Oversight and/or Head of GXP Support . Multiple internal relationships exist with personnel at all… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... in project teams.Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.Interacts… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... lead in project teams.Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics.Lead the… more
- Merck & Co. (Rahway, NJ)
- …delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions ... is accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (eg, CCDS, CCPPI,… more
- Novo Nordisk Inc. (Chicago, IL)
- … strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...external customers to further scientific exchange. S/he provides advanced product and scientific and medical field support … more
- Merck & Co. (North Wales, PA)
- …the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- …team, Key Opinion Leader engagement execution, competitive strategy, target product profile development, health authority interactions, global regulatory ... for maximizing physician acceptance, market penetration, profitability, and new indication/ product launch uptake.Provides leadership, support , and expertise to… more
- Merck & Co. (Rahway, NJ)
- …the Associate Director, will participate in and/or lead various initiatives in support of our Manufacturing and Research Division's QMS Purchasing Control objectives ... other Quality Programs, as assigned. Understands the evolving global health authority regulatory requirements and works proactively to assure our company's is in a… more
- Merck & Co. (Rahway, NJ)
- …the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Durham, NC)
- …and collaboration skills responsible for supporting Operational Readiness projects to support biological processes for a new manufacturing facility or currently ... to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend... at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for… more
- Novo Nordisk Inc. (Chicago, IL)
- …up-to-date information on the therapeutic area and NNI clinical plans and study results, product support letters, and the Marketing and Sales product plan ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (Durham, NC)
- …Maintenance Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility - project/manufacturing - ... supporting: - Process Equipment (eg tanks/bioreactors, filtration skids, chromatography columns)- Support Equipment (eg washers, autoclaves, tube - welders/sealers, WFI… more
- Merck & Co. (Rahway, NJ)
- …our Company's products and interests from the world's biomedical literature in support of regulatory , clinical research, marketing, and legal functions.- Plans, ... Develops, with input from internal stakeholders and knowledge of current regulatory requirements, article selection, adverse event reporting, editorial, and indexing… more
- Novo Nordisk Inc. (Chicago, IL)
- … strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and assists the Program… more
- Merck & Co. (North Wales, PA)
- …BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our Research and Development Division pre- ... member in the Risk Management Safety Teams.- Lead and provide statistical support for related drug/vaccine projects in Clinical Safety StatisticsInteract with Safety… more
